Risk Factors Update Summary

• The company faces heightened risks in obtaining marketing authorization in the U.K. post-Brexit. This change might result in delays affecting revenue generation.
• Our net losses increased from $94.7 million to $164 million for the years ended December 31, 2023 and 2022. This change might result in heightened investor concern regarding financial stability.
• The FDA's recent draft guidance on off-label promotion could expose the company to significant liability. This change may lead to increased regulatory scrutiny and potential penalties.
• The accumulated deficit rose from $558 million to $722 million as of December 31, 2023. This change indicates a significant increase in financial risk for investors.
• The Consolidated Appropriations Act delays the 4% Medicare payment reduction until the end of 2024. This change could positively impact revenue stability for the company.
• We announced a strategic realignment to prioritize tamibarotene development, ceasing investment in SY-2101 and SY-5609. This change may impact future revenue streams and market positioning.
• The company reported federal and state net operating loss carryforwards of $348 million and $349 million, respectively. This change may affect future tax liabilities and cash flow.
• Failure of Qiagen to develop a companion diagnostic for tamibarotene could harm commercialization efforts. This change emphasizes reliance on third-party collaborations for successful product launches.
• Eleven states have passed comprehensive privacy laws similar to the CCPA, impacting business operations. This change could increase compliance costs and operational complexities.
• We plan to build a specialized sales and marketing organization for tamibarotene in the U.S. This change reflects a commitment to enhancing commercialization efforts, which may improve market penetration.